Amoeba: Malta recommends the non-approval of the “biocide” active substance for the European territory
Amoeba announces that the Maltese authority recommends the non-approval of the biocidal active substance for the European territory
Lyon (France), May 3rd, 2022 – 17h45 – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product
for plant protection, still in development phase, announces that the MCCAA (Malta Competition and
Consumer Affairs Authority), the competent authority of the reporting Member State (Malta)
evaluating the application for approval of the biocidal active substance “Willaertia magna C2c Maky”,
recommends its non-approval for a biocidal use in cooling towers in Europe.
On the basis of the application for approval of the biocidal active substance “Willaertia magna C2c
Maky”, the Maltese authority concluded in its draft report that the active substance is not likely to
fulfill the approval criteria, considering that the innate efficacy was not sufficiently demonstrated and
that a Trojan horse effect cannot be excluded under realistic conditions of application and use.
Malta therefore recommends to the other EU Member States and to the European Chemicals Agency
(ECHA) that the substance should not be approved and therefore not included in the list of authorized
biocidal active substances.
The Maltese draft assessment report will now be discussed at the European level between Member
States under the aegis of ECHA, before a decision by the European Commission in mid-2023.
“The Trojan Horse effect is purely hypothetical and has never been characterized as a danger.
Regarding the efficacy, European regulations require at the stage of the active substance approval to
demonstrate the capacity of the substance to produce a sufficient effect on a relevant target organism:
the studies conducted by Amoeba have largely shown this ability of Willaertia magna C2c Maky against
legionella. Again, the evaluators question the methodology of our studies while the biocidal standards
are exclusively developed for chemicals and do not exist for microorganisms, creating a barrier to
access the biocidal market for this type of natural substance. The recommendation of non-approval by
Malta is hence an outcome tinged with misunderstanding. “, declares Jean-Baptiste EBERST, Regulatory Director at Amoéba.
“At the dawn of the greatest environmental and health challenges, the unfavorable decision of the
Maltese authority causes disappointment and dismay to Amoeba and its teams. This conclusion goes
against the objectives of the European Commission, which has just published its roadmap on the
restriction of harmful chemicals. Nevertheless, we have just secured Amoéba on a more than €12
billion market thanks to the positive recommendation on biocontrol, which is a major step forward for
a Greentech. Our plant in Chassieu, already 100% dedicated to biocontrol, will provide us with
biocontrol active substance for the years to come. We are also convinced by the strong potential of the
amoeba and are pursuing our development and research in other application areas.” states Fabrice
Plasson, CEO of Amoéba.
Pending application for authorization of its biocide in the United States and Canada
Amoéba reminds that the application for approval of the biocidal active substance, the living amoeba
Willaertia magna C2c Maky, and biocidal products containing it, filed in April 2021 with the U.S.
Environmental Protection Agency (U.S. EPA), is still under review. The conclusions are expected by mid2022.
In Canada, the application for registration of the active substance and biocidal products containing it,
submitted in 2019, is under evaluation. The decision of the Canadian agency could be communicated
in 2022.
Continued development of the biocontrol application
At the same time, Amoéba continues to develop its biocontrol application, especially through
collaborations with its partners and other major players in the plant protection sector through new
field trial campaigns.
In Europe, the Austrian authority has recommended in April 2022 the approval of the biocontrol active
substance.
In the United States, the application for approval of the active substance and products containing it,
also submitted in 2020, is being evaluated.
Finally, in Brazil, an experimental permit was obtained in February 2021, allowing the Company to
initiate field trials on soybean, coffee and banana. Such trials in Brazil are required for an application
for approval.